510(k) Report

Devices descending from K172135

12 later devices reach uCT Computed Tomography X-ray System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K230162uCT 760 with uWS-CT-Dual Energy Analysis, uCT 780 with uWS-CT-Dual Energy AnalysisShanghai United Imaging Healthcare Co., Ltd.202324
+1K203448uCT ATLAS with uWS-CT-Dual Energy AnalysisShanghai United Imaging Healthcare Co., Ltd.202163
+1K193073Deep ReconShanghai United Imaging Healthcare Co., Ltd.20200—
+1K200016uCT 530, uCT 550Shanghai United Imaging Healthcare Co., Ltd.202014
+1K181414uCT 530, uCT 550Shanghai United Imaging Healthcare Co., Ltd.2018310
+2K241166uCT 550Shanghai United Imaging Healthcare Co., Ltd.202501
+2K241079uCT 780Shanghai United Imaging Healthcare Co., Ltd.202512
+2K231482uCT ATLAS Astound with uWS-CT-Dual Energy Analysis, uCT ATLAS with uWS-CT-Dual Energy…Shanghai United Imaging Healthcare Co., Ltd.202313
+2K223028uCT ATLAS Astound with uWS-CT-Dual Energy AnalysisShanghai United Imaging Healthcare Co., Ltd.20232—
+2K183143uCT 520, uCT 528Shangai United Imaging Healthcare Co., Ltd.20190—
+3K253173uCT 780 with uWS-CT-Dual Energy AnalysisShanghai United Imaging Healthcare Co., Ltd.202601
+3K243617uCT ATLAS Astound with uWS-CT-Dual Energy Analysis; uCT ATLAS with uWS-CT-Dual Energy…Shanghai United Imaging Healthcare Co., Ltd.202503